RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy - Evaluating Function and Quality of Life: A National, Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
- Primary Endpoint
- Proportion of patients with a clinically significant change in fecal incontinence
Study Overview
Brief Summary
The goal of this observational study is to learn how a common surgery called lateral internal sphincterotomy (LIS) affects people with chronic anal fissures, a painful tear near the anus. The study will look at whether this surgery helps lower problems like pain and incontinence, and how it affects quality of life and mental health.
The main questions the study aims to answer are:
Does LIS surgery lower the rate of incontinence one year after surgery? Does it improve quality of life, reduce pain, and increase patient satisfaction?
Participants will:
Have surgery for chronic anal fissure called LIS. Complete short surveys about pain and mental health at 1 week, 3 months, and 12 months.
Answer questions about bowel function, incontinence and daily life at 3 and 12 months.
Researchers will follow about 300 adults at hospitals across the Turkey. This study will help improve future treatment decisions and make surgery safer and more effective.
Detailed Description
Chronic anal fissure is a common anorectal condition that can significantly affect daily life due to pain and difficulty with bowel movements. Lateral internal sphincterotomy (LIS) is a widely used surgical treatment for fissures that do not improve with medical therapy. While LIS is highly effective in promoting healing, it may lead to complications such as fecal incontinence, which can negatively affect quality of life.
The RELIEF Study is a prospective, multicenter cohort study conducted across several hospitals in Turkey. The aim is to evaluate the long-term effects of LIS on bowel control, postoperative pain, patient satisfaction, and mental health. Participants will be followed for 12 months after surgery. Data will be collected using a secure electronic data capture system (REDCap) to ensure standardization and data quality.
Approximately 300 adult participants will be enrolled. Researchers will examine different surgical approaches to LIS, including tailored techniques (based on fissure location or sphincter tone) and classical methods (such as sphincterotomy to the fissure apex). By comparing outcomes across these techniques, the study will help identify safer and more effective strategies.
Validated tools, including incontinence scores, pain scales, and quality of life questionnaires, will be used to measure outcomes. The findings are expected to inform clinical practice and contribute to the development of evidence-based guidelines for the treatment of chronic anal fissures.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 years or older
- •Diagnosed with chronic anal fissure (symptoms lasting more than 6 weeks)
- •Decision for lateral internal sphincterotomy (LIS) made by the treating physician
- •Able to understand and complete study-related questionnaires
Exclusion Criteria
- •Presence of other anorectal or rectal diseases (e.g., fistula, abscess, inflammatory bowel disease)
- •History of prior anal surgery or pelvic radiation
- •Inability to comprehend study-related forms or provide informed consent
Outcomes
Primary Outcomes
Proportion of patients with a clinically significant change in fecal incontinence
Time Frame: Baseline, 12 months postoperatively
A clinically significant improvement is defined as a reduction of ≥2 points in the Cleveland Clinic Incontinence Score (Wexner Score), which ranges from 0 (perfect continence) to 20 (complete incontinence). Higher scores indicate worse fecal incontinence. The proportion of patients achieving this threshold will be calculated at 12 months postoperatively.
Secondary Outcomes
- Fecal Incontinence Quality of Life (FIQoL) Scale Score(Baseline, 3 - 12 months after surgery)
- Short Form-36 (SF-36) Health Survey Score(Baseline, 3 - 12 months after surgery)
- Change in disease-specific quality of life measured by the Hemo-Fiss-QoL questionnaire(Baseline, 3 - 12 months after surgery)
- Change in Anxiety and Depression Scores (HADS)(7-10 days, 3 months, 12 months)
- Change in Pain Scores Using Visual Analog Scale (VAS)(7-10 days, 3 months, 12 months)
- Patient Satisfaction Score(12 months after surgery)